- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05545709
5G-based Telerobot-assisted Spine Surgery
Clinical Application of 5G-based Telerobot-assisted Spine Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Local orthopedic robot-assisted spine surgeries were performed according to the guidelines for thoracolumbar pedicle screw placement assisted by orthopedic surgical robots.
Based on the 5G network, the orthopedic robotic remote surgery platform is built at Beijing Jishuitan Hospital, providing primary hospitals with a platform for preoperative consultation, intraoperative communication and surgical robot teleoperation, and postoperative follow-up. With the support of the 5G network, equipment and surgical robots are integrated into the remote surgery service platform, building a high-speed transmission channel between Beijing Jishuitan Hospital and other hospitals.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100000
- Beijing Jishuitan Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients received remote robot-assisted spinal surgery or local orthopedic robot-assisted spinal surgery;
- patients had complete medical records and imaging data;
- patients provided informed consent.
Exclusion Criteria:
- revision surgery;
- more than four surgical segments;
- patients with severe comorbidities.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
remote group
Based on the 5G network, the orthopedic robotic remote surgery platform is built at Beijing Jishuitan Hospital, providing primary hospitals with a platform for preoperative consultation, intraoperative communication and surgical robot teleoperation, and postoperative follow-up.
With the support of the 5G network, equipment and surgical robots are integrated into the remote surgery service platform, building a high-speed transmission channel between Beijing Jishuitan Hospital and other hospitals.
|
Based on the 5G network, the orthopedic robotic remote surgery platform is built at Beijing Jishuitan Hospital, providing primary hospitals with a platform for preoperative consultation, intraoperative communication and surgical robot teleoperation, and postoperative follow-up.
With the support of the 5G network, equipment and surgical robots are integrated into the remote surgery service platform, building a high-speed transmission channel between Beijing Jishuitan Hospital and other hospitals.
|
|
local group
Local orthopedic robot-assisted spine surgeries were performed according to the guidelines for thoracolumbar pedicle screw placement assisted by orthopedic surgical robots.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The accuracy of guide-wire placement or positioning
Time Frame: 1 month
|
according to the Gertzbein and Robbins scale, including grade A (screw was completely within the pedicle), grade B (pedicle cortical breach <2 mm), grade C (pedicle cortical breach <4 mm), grade D (pedicle cortical breach <6 mm), and grade E (pedicle cortical breach >6 mm).
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
operation time
Time Frame: 1 day
|
Time from start to finish of surgery
|
1 day
|
|
complication
Time Frame: 1 month
|
Nerve injury, epidural hematoma, and infection
|
1 month
|
|
network interruptions
Time Frame: 1 day
|
failure to establish connection, the interruption of connection and severe delays in connection, and remote surgery abandonment.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wei Tian, Beijing Jishuitan Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- JST 202005-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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